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FDA 510(k)

HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193

K-Number: K853003 · 1985-08-06

ApplicantHi Chem, Inc.
Decision Date1985-08-06
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1985-08-06 under 510(k) number K853003. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193?

HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 is a medical device that received FDA 510(k) clearance on 1985-08-06. The listed applicant is Hi Chem, Inc.. The 510(k) number is K853003.

When did HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 receive FDA 510(k) clearance?

HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 received FDA 510(k) clearance on 1985-08-06, under 510(k) number K853003.

Who is the listed applicant for HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193?

The FDA 510(k) record lists Hi Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193?

The FDA product code for HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 is JJE.

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Other records listing Hi Chem, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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Related Devices (Code: JJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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